Allergy medication recalled for potential cross-contamination that could be life-threatening, FDA says
A pharmaceutical company has voluntarily recalled a select number of its allergy medications after cross-contamination with a drug used for heartburn and severe acid reflux, according to the U.S. Food and Drug Administration.
"Unique Pharmaceutical Laboratories is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross contamination with Ranitidine," an FDA notice reads.
The contamination could potentially be life-threatening, specifically for those with severe allergies or anaphylaxis to certain ingredients, the FDA says.
The recall was announced by the company on July 18 and posted by the FDA this week.
According to the notice, Unique Pharmaceutical Laboratories, which is a division of J. B. Chemicals & Pharmaceuticals Ltd., voluntarily recalled four lots of the antihistamine due to cross contamination with ranitidine, a drug focused on treating stomach acid ailments.
According to a risk statement posted to the announcement, for those with a hypersensitivity to ingredients in Ranitidine, "there is a reasonable probability" that taking the recalled Cetirizine tablets with ranitidine could result in a number of potentially "life-threatening" events.
The potential risks to those with adverse reactions to ranitidine who then ingest cross-contaminated cetirizine may include "severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness."
The release adds, "To date, Unique Pharmaceuticals has not received any reports of adverse events related to this recall."
The release notes the effected product is in an HDPE Bottle pack of 100 tablets with an (NDC: 16571-401-10).
"Product complaint received that a pharmacy technician identifies the discrepancy while counting the tablets at the time of dispensing," reads the announcement. "A product complaint reported about Appearance of red dot on Tablets of Cetirizine Hydrochloride Tablets USP 5 mg and some tablets are discolored (Appeared as discolored due to multiple red colored dots on tablets)."
All details related to the NDC, manufacturer, distributor, product design, lot numbers and expiration dates associated with affected products can be found on the FDA recall here.
The release notes that Unique Pharmaceutical's notified its distributor Rising Pharma Holdings Inc., and Rising Pharma Holdings Inc. notified its distributors, customers and "is arranging for the return of all recalled products."
ABC News has reached out to Rising Pharma Holdings Inc. for additional comment.
"Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax," reads the notice.
